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Hernia-Prophylaxis in Acute Care Surgery H-PACS (H-PACS)

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Strattice
Single running suture of abdominal fascia
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing emergency midline laparatomy
  • Emergency laparoscopy with expected conversion to midline laparatomy
  • Written informed consent

Exclusion Criteria:

  • ASA ≥5
  • Septic shock
  • Pregnant women
  • Prior mesh Implantation
  • Known sensitivity for porcine material or Polysorbate 20

Sites / Locations

  • Dep. of Visceral and transplant surgery, Berne University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mesh implantation

Single running suture of abdominal fascia

Arm Description

Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion

The closure of the abdominal wall a Standard technique will be applied using a running suture

Outcomes

Primary Outcome Measures

Number of incidence of death
follow-up
Number of patients with hernia free survival
follow-up

Secondary Outcome Measures

Number of patients with postoperative fascial dehiscence
follow-up
Number of postoperative mortality
survival
Number of surgical site infections postoperative
follow-up
Number of postoperative intestinal fistulas
follow-up
Number of small bowel obstructions
follow-up
Number of patients with postoperative pain
follow-up
Number of postoperative mesh infections
follow-up
Number of postoperative mesh explantations
follow-up

Full Information

First Posted
March 20, 2017
Last Updated
October 25, 2021
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03090022
Brief Title
Hernia-Prophylaxis in Acute Care Surgery H-PACS
Acronym
H-PACS
Official Title
Prophylactic Mesh Implantation in Patients Undergoing Requiring Emergency Laparatomy for the Prevention of Incisional Hernia:A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 5, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%. The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly. The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe . With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesh implantation
Arm Type
Active Comparator
Arm Description
Prior to closure of the abdominal wall a mesh will be implanted in a standardized fashion
Arm Title
Single running suture of abdominal fascia
Arm Type
Active Comparator
Arm Description
The closure of the abdominal wall a Standard technique will be applied using a running suture
Intervention Type
Procedure
Intervention Name(s)
Strattice
Other Intervention Name(s)
Acellular porcine dermal mesh
Intervention Description
Intra-abdominally Fixation
Intervention Type
Procedure
Intervention Name(s)
Single running suture of abdominal fascia
Intervention Description
Intra-abdominal suture
Primary Outcome Measure Information:
Title
Number of incidence of death
Description
follow-up
Time Frame
up to 18 months
Title
Number of patients with hernia free survival
Description
follow-up
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Number of patients with postoperative fascial dehiscence
Description
follow-up
Time Frame
30 days
Title
Number of postoperative mortality
Description
survival
Time Frame
90 days
Title
Number of surgical site infections postoperative
Description
follow-up
Time Frame
30 days
Title
Number of postoperative intestinal fistulas
Description
follow-up
Time Frame
30 days
Title
Number of small bowel obstructions
Description
follow-up
Time Frame
18 months
Title
Number of patients with postoperative pain
Description
follow-up
Time Frame
18 months
Title
Number of postoperative mesh infections
Description
follow-up
Time Frame
18 months
Title
Number of postoperative mesh explantations
Description
follow-up
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing emergency midline laparatomy Emergency laparoscopy with expected conversion to midline laparatomy Written informed consent Exclusion Criteria: ASA ≥5 Septic shock Pregnant women Prior mesh Implantation Known sensitivity for porcine material or Polysorbate 20
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Beldi, Prof. Dr.
Organizational Affiliation
Inselspital Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Visceral and transplant surgery, Berne University Hospital
City
Berne
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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Hernia-Prophylaxis in Acute Care Surgery H-PACS

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